A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Senese
• Treatments: Antibodies, Monoclonal; Tremelimumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed malignant mesothelioma (MM)

• Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM

• Disease not amenable to curative surgery

• No known brain metastasis

• Age 18 and over

• Performance status 0-2

• Life expectancy > 12 weeks

• Adequate hematologic, hepatic and renal function

• Not pregnant or nursing

• Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution

Exclusion Criteria:

• Symptomatic chronic inflammatory or autoimmune disease

• Active hepatitis B or C

• Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or not compensated chronic heart disease in NYHA class II or more

• History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent

• Uncontrolled active infections

• Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents

• History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years